MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX 3D; BREAST - ABSORBABLE MESH

Model Number	100042-06
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent a breast implant exchange on (b)(6) 2025.About 5 weeks postop, the patient presented in with an unspecified infection very late in the healing process on the right breast.On (b)(6) 2025, patient underwent removal of the mesh as it was potential affected by the infection and was treated with antibiotics.
Additional Manufacturer Narrative
As reported, the patient was diagnosed with postoperative infection following the implantation of galaflex 3d which potentialy affected the mesh, so it was removed.Based on the information available, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient¿s postoperative course.A review of the manufacturing records was performed and found the lot was manufactured to specification.Infection is a known inherent risk with the use of this product, and it is listed in the adverse reactions section of the instructions-for-use supplied with the device, as possible complication.Regarding infection, the warning section states "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: GALAFLEX 3D
• Common Device Name: BREAST - ABSORBABLE MESH
• Manufacturer (Section D): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer (Section G): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 22676247
• Report Number: 1213643-2025-00700
• Device Sequence Number: 8742950
• Product Code: OOD
• UDI-Device Identifier: 00810054980315
• UDI-Public: (01)00810054980315(17)270530(10)LXHW0007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 100042-06
• Device Catalogue Number: SH3D06
• Device Lot Number: LXHW0007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female